A Bioequivalence Study of Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets in Healthy Thai Volunteers Under Fasting Condition
Sponsor study identifier
interventional
40
0 countries
N/A
Study Start
May 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 22, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be a randomized, open-label, single oral dose, full replicated crossover design with four-period, two-treatment, and two-sequence under fasting condition and at least 14 days washout period between the doses.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2024
Actual (reported)February 8, 2024
Actual (reported)May 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 22, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)
pre-dose (0.000 hour) and at 0.083, 0.167, 0.333, 0.500, 0.670, 0.830, 1.000, 1.330, 1.670, 2.000, 2.500, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000 and 48.000 hours post-dose
Blood samples will be collected for PK an pre-dose and at 0.083, 0.167, 0.333, 0.500, 0.670, 0.830, 1.000, 1.330, 1.670, 2.000, 2.500, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000 and 48.000 hours post-dose
Maximal measured plasma concentration (Cmax)
pre-dose (0.000 hour) and at 0.083, 0.167, 0.333, 0.500, 0.670, 0.830, 1.000, 1.330, 1.670, 2.000, 2.500, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000 and 48.000 hours post-dose
Blood samples will be collected for PK an pre-dose and at 0.083, 0.167, 0.333, 0.500, 0.670, 0.830, 1.000, 1.330, 1.670, 2.000, 2.500, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000 and 48.000 hours post-dose
Number of subjects with adverse events
Approximately the day 14 after the last visit
Participants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Sacubitril 97 mg and Valsartan 103 mg test product, treatment 2= Sacubitril 97 mg and Valsartan 103 mg reference product.
Participants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Sacubitril 97 mg and Valsartan 103 mg test product, treatment 2= Sacubitril 97 mg and Valsartan 103 mg reference product.
Test-Product: Sacubitril 97 mg and Valsartan 103 mg film-coated tablets Manufactured by: Hetero Labs Ltd., India
Reference-product: ENTRESTOTM (Film-Coated Tablets) 97/103 mg Manufactured by: Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd., Singapore for Novartis Pharma AG, Basle, Switzerland
First Submitted
January 31, 2024
First Posted
February 8, 2024
Study Start
May 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 22, 2024
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/1000 mg Relative to Originator
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 8, 2024
Record last verified: 2024-01
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